Trial Outcomes & Findings for Zoledronic Acid and Positron Emission Tomography in Treating Patients With Advanced Non-Small Cell Lung Cancer (NCT NCT00559897)
NCT ID: NCT00559897
Last Updated: 2015-02-04
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
FLT PET scan will be done 6-8 days after the dose of zoledronic acid
Results posted on
2015-02-04
Participant Flow
Participant milestones
| Measure |
3'-Deoxy-3'-[18F]FLT PET & Zoledronic Acid
Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid
Single photon emission computed tomography. Patient should receive the dose of zoledronic acid within 48 hrs of the first '3'-deoxy-3'-\[18F\]FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.
3'-deoxy-3'-\[18F\]FLT: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.
Single photon emission computed tomography: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.
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|---|---|
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Overall Study
STARTED
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6
|
|
Overall Study
COMPLETED
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6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Zoledronic Acid and Positron Emission Tomography in Treating Patients With Advanced Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
3'-Deoxy-3'-[18F]FLT PET & Zoledronic Acid
n=6 Participants
Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid
Single photon emission computed tomography. Patient should receive the dose of zoledronic acid within 48 hrs of the first '3'-deoxy-3'-\[18F\]FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.
3'-deoxy-3'-\[18F\]FLT: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.
Single photon emission computed tomography: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
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5 Participants
n=5 Participants
|
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Age, Categorical
>=65 years
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1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: FLT PET scan will be done 6-8 days after the dose of zoledronic acidOutcome measures
Outcome data not reported
Adverse Events
3'-Deoxy-3'-[18F]FLT PET & Zoledronic Acid
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
3'-Deoxy-3'-[18F]FLT PET & Zoledronic Acid
n=6 participants at risk
Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid
Single photon emission computed tomography. Patient should receive the dose of zoledronic acid within 48 hrs of the first '3'-deoxy-3'-\[18F\]FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.
3'-deoxy-3'-\[18F\]FLT: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.
Single photon emission computed tomography: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.
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|---|---|
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Psychiatric disorders
Altered Mental Status
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16.7%
1/6 • Number of events 1 • At week 3
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Other adverse events
Adverse event data not reported
Additional Information
Dr. Shirish Gadgeel
Barbara Ann Karmanos Cancer Institute
Phone: 313-576-8753
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place